DUBLIN – Sanofi SA is paying $1.1 billion up front and up to $350 million more in potential clinical development and regulatory milestones to acquire antibody developer Kymab Ltd. The deal adds to Sanofi’s pipeline first-in-class OX40-ligand blocker KY-1005, which recently hit the primary endpoints of a phase IIa trial in atopic dermatitis, as well as a second clinical-stage asset, KY-1044, an ICOS agonist in development for solid tumors. It also brings Sanofi a new antibody discovery platform, comprising several transgenic mouse strains, which collectively encode all the building blocks required to produce fully human antibodies. Read More
As a virtual 39th J.P. Morgan Annual Healthcare Conference begins, typically one of the biggest events of the year, biopharma dealmaking barreled ahead with five new deals Jan. 11 that could eventually hit $1.04 billion in total. Read More
A decade from now, 2020 likely will be considered a year like no other in terms of the massive amounts of capital raised amid a raging pandemic. Financing transactions of all types smashed records and in terms of volume hit 1,580, a total that was 42% higher than last year despite the serious disruptions to normal business operations. Read More
The attention the COVID-19 pandemic drew to the biopharma industry, the ease and convenience of virtual meetings, as well as massive amounts of available capital, all led to an extraordinary year for financings in 2020. The momentum appears to be continuing, particularly with venture capital rounds. Read More
Shares of Eli Lilly and Co. (NYSE:LLY) leapt 11.7% to $185.94, their second biggest gain since 2010, after a phase II trial showed its beta-amyloid-targeting monoclonal antibody, donanemab, appeared to slow by 32% decline in a composite measure of cognition and daily function in patients with early symptomatic Alzheimer’s disease vs. placebo. Read More
Bluebird Bio Inc. CEO Nick Leschly conceded that it’s “hard for folks on the outside looking in” to understand why the firm would cleave its severe genetic disease (SGD) and oncology efforts into two independently traded public companies, but said the Cambridge, Mass.-based firm is making the change by the end of this year in order “to make sure we can basically fall down and get back up and learn everything we can in the most disciplined manner,” he said. Read More
LONDON – The 1,246 pages that make up the U.K./EU post-Brexit trade deal have “one paragraph we can build on,” said Steve Bates, chief executive of the Bioindustry Association (BIA), giving his initial reaction to the document published late on Dec. 24. That one paragraph refers to the setting up of a joint working group on medicinal products. It says the EU and the U.K. “shall endeavour to cooperate with a view to strengthening, developing and promoting adoption and implementation of internationally agreed scientific or technical guidelines.” Read More
CAJICA, Colombia – A phase III trial for an HIV vaccine developed Janssen Vaccines & Prevention BV is finally moving forward in Latin America and elsewhere in the world after a delay of more than a year caused by slow regulatory progress and worsened by a string of COVID-19 lockdowns. Read More
HONG KONG – Tapping into synergies it sees between the U.S. and Chinese biotech industries, Suzhou, China-based Ascentage Pharma Group Corp. Ltd. is aiming to get its most advanced candidate, HQP-1351 (olverembatinib dimesylate) to market this year for patients with TKI-resistant chronic myeloid leukemia. Read More
Despite a circuit split on the issue, the U.S. Supreme Court Dec. 11 rejected an appeal by Bristol Myers Squibb Co. (BMS) and Sanofi SA over giving states a “second bite at the apple” in whistleblower cases. Read More
The latest global regulatory news, changes and updates affecting biopharma, including: Drug safety in pregnancy mission of new U.K. consortium; FDA identifies regulatory science needs; HHS finalizes regulatory review rule; Doctor pleads guilty to trial fraud. Read More
New hires and promotions in the biopharma industry, including: Arcutis, Biocardia, City of Hope, Deinove, Denali, Dyadic, Intercept, Modulus Oncology, Mydecine, Valneva, Xbrane, Ziphius Vaccines. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aerie, Amydis, Axcella, Boehringer, Chipscreen, Cytokinetics, Editas, Eli Lilly, Ideaya, Istari, Exicure, Lysogene, Neuren, Obseva, Organogenesis, RDIF, Receptor Life Sciences, Roche. Read More
